Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164, 1st Edition (Hardback) book cover

Electronic Record Keeping

Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164, 1st Edition

By David Nettleton, Janet Gough

CRC Press

384 pages | 2 B/W Illus.

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Hardback: 9780849321641
pub: 2003-12-29
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Description

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance.

Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean.

Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive.

Table of Contents

ELECTRONIC RECORD KEEPING: THE BIG PICTURE

Regulatory Evolution

The Electronic Revolution

Compliance Requirements

General Basis for Electronic Records

Security, Data Transfer, Operation Checks, Archiving, and Audit Trails

THE REGULATIONS: NOT JUST WHAT THEY SAY, BUT WHAT THEY MEAN

21 CFR Part 11 Electronic Records; Electronic Signatures and 45 CFR Parts 160, 162, and 164 Health Insurance Reform: Security Standards

GOING ELECTRONIC: WHAT YOU NEED TO KNOW AND DO

Software Development and Use: From Then Till Now

The COTS Software Development Life Cycle

Purchasing COTS Software

Developer and User Validation

Operating Environments

IQ/OQ/PQ and CSV

Retrospective Validation

DOCUMENTATION AND TRAINING

The Validation Packet

Validation Documents

System Support Documents

Additional Records

Training

SECURITY, ACCOUNTABILITY, AND CHANGE MANAGEMENT

Managing the System

Security and the People Factor

Ongoing Communication

Managing Passwords: A Keychain

Biometric Keychains

Change Management

AUDITING ELECTRONIC RECORD KEEPING SYSTEMS

Establishing an Audit Function

Establishing the Scope of the Audit and preparing to Audit

Reviewing Binding Regulations and Documentation

Planning the Audit

Conducting the Actual Audit

Evaluating and Reporting Results

Keeping the Audit Function Vital

Auditing and the Regulatory Inspection

MOVING FORWARD

Computer System Validation Committee

Changing Company Cultures

Gap Analysis

Computer System Inventory

Remaining Vigilant

FREQUENTLY ASKED QUESTIONS

Binding Regulations

Software Vendors

Computer System Validation

Electronic Records

Electronic Signatures and Accountability

Security

Systems

Audit Trails

Staying Informed

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology